Methods and devices for use in performing pulmonary procedures

ABSTRACT

Systems, methods and devices for performing pulmonary procedures, and in particular treating lung disease. A flow control element includes a valve that prevents airflow in the inhalation direction but permits airflow in the exhalation direction. The flow control element is guided to and positioned at the site by a bronchoscope that is introduced into the patient&#39;s trachea and used to view the lungs during delivery of the flow control element. The valve may include one, two or more valve elements, and it may be collapsible for easier delivery. A source of vacuum or suction may be used to increase the amount of fluid withdrawn from the lung tissue. A device for measuring hollow structures, such as bronchioles, and a device for removing a previously-placed flow control element are disclosed as well.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.09/519,735 filed Mar. 4, 2000 now U.S. Pat. No. 6,679,264 entitled“Methods and Devices for use in Performing Pulmonary Procedures” by Deemet al., the full disclosure of which is incorporated herein byreference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to methods and devices for usein performing pulmonary procedures, and more particularly, proceduresfor treating various diseases of the lungs.

2. Description of Related Art

Pulmonary diseases such as emphysema and chronic obstructive pulmonarydisease (COPD) reduce the ability of one or both lungs to fully expelair during the exhalation phase of the breathing cycle. The diseasedlung tissue is less elastic than healthy lung tissue, which is onefactor that prevents full exhalation of air. During breathing, thediseased portion of the lung does not fully recoil due to the tissuebeing less elastic. Consequently, the diseased (e.g., emphysematic) lungtissue exerts a relatively low driving force, which results in thediseased lung expelling less air volume than a healthy lung. The reducedair volume exerts less force on the airway which allows the airway toclose before all air has been expelled, another factor that preventsfull exhalation.

The problem is further compounded by the diseased, less elastic tissuethat surrounds the very narrow airways that lead to the alveoli (the airsacs where oxygen-carbon dioxide exchange occurs). This tissue has lesstone than healthy tissue and is typically unable to maintain the narrowairways open until the end of the exhalation cycle. This traps air inthe lungs and exacerbates the already-inefficient breathing cycle. Thetrapped air causes the tissue to become hyper-expanded and no longerable to effect efficient oxygen-carbon dioxide exchange. Applyingsuction to these narrow airways (a procedure proposed in the literaturefor deflating the diseased portion of the lung) may collapse the airwaysdue to the surrounding diseased tissue, thereby preventing successfulfluid removal.

In addition, hyper-expanded lung tissue occupies more of the pleuralspace than healthy lung tissue. In most cases, a portion of the lung isdiseased while the remaining part is healthy and therefore still able toefficiently carry out oxygen exchange. By taking up more of the pleuralspace, the hyper-expanded lung tissue reduces the amount of spaceavailable to accommodate the healthy, functioning lung tissue. As aresult, the hyper-expanded lung tissue causes inefficient breathing dueto its own reduced functionality and because it adversely affects thefunctionality of adjacent healthy tissue.

Lung reduction surgery is a conventional method of treating lungdiseases such as emphysema. A diseased portion of the lung is surgicallyremoved which makes more of the pleural space available to accommodatethe functioning, healthy portions of the lung. The lung is typicallyaccessed through a median sternotomy or small lateral thoracotomy. Aportion of the lung, typically the upper lobe of each lung, is freedfrom the chest wall and then resected, e.g., by a stapler lined withbovine pericardium to reinforce the lung tissue adjacent the cut lineand also to prevent air or blood leakage. The chest is then closed andtubes are inserted to remove air and fluid from the pleural cavity. Theconventional surgical approach is relatively traumatic and invasive,and, like most surgical procedures, is not a viable option for allpatients.

More recently proposed treatments include the use of devices that employRF or laser energy to cut, shrink or fuse diseased lung tissue. Anotherlung volume reduction device utilizes a mechanical structure that isused to roll the lung tissue into a deflated, lower profile mass that ispermanently maintained in a compressed condition. As for the type ofprocedure used, open surgical, minimally invasive and endobronchialapproaches have all been proposed. Another proposed device (disclosed inpublication no. WO 98/48706) is positioned at a location in the lung toblock airflow and isolate a part of the lung. The publication statesthat the occlusion device is introduced through an endobronchialdelivery device, and is resiliently deformable in order to provide acomplete seal against airflow.

The search for new and better treatments underscores the drawbacksassociated with existing pulmonary procedures. Accordingly, there is aneed in the art for improved methods and devices for performingpulmonary procedures, and in particular, treating lung diseases such asemphysema.

SUMMARY OF THE INVENTION

In one embodiment the invention provides a method for treating apatient's lung. The method includes steps of selecting a hollowstructure in a patient's lung, the hollow structure defining a pathwayfor conducting fluid flow in at least first and second directions, andallowing fluid flow within the pathway in the first direction whilecontrolling fluid flow in the second direction.

In another embodiment the invention provides a method for treating apatient's lung. This method includes steps of providing a valve whichallows fluid flow in a first direction and limits fluid flow in a seconddirection, and positioning the valve at a desired location in a lung ofa patient with the first direction corresponding to an exhalationdirection and the second direction corresponding to an inhalationdirection.

In another embodiment the invention provides a method for treating apatient's lung that includes steps of providing a flow control elementthat limits fluid flow in at least one direction, positioning the flowcontrol element at a location in a lung of a patient with the onedirection substantially corresponding to an inhalation direction, andremoving the flow control element after a period of time.

In another embodiment the invention provides a method for treating apatient's lung, the method comprising steps of selecting a hollowstructure in a patient's lung, the hollow structure defining a pathwayfor conducting fluid flow in at least first and second directions,applying suction to draw fluid through the pathway in the firstdirection, and substantially preventing fluid flow through the pathwayin the second direction.

In another embodiment the invention provides a system for treating apatient's lung. The system includes a flow control element sized andconfigured to be positioned in a hollow structure located in a patient'slung, the flow control element including a valve member that permitsfluid flow in a first direction while substantially preventing fluidflow in a second direction. A delivery device is sized and configured tobe guided to and positioned in or adjacent the hollow structure, and theflow control element is removably mounted on the delivery device.

In another embodiment the invention provides a system for treating apatient's lung. The system includes a measuring device for determiningthe approximate size of a hollow structure in a patient's lung, and aflow control element sized and configured to be positioned in a hollowstructure located in a patient's lung, wherein the flow control elementallows fluid flow in a first direction but substantially prevents fluidflow in a second direction.

In another embodiment the invention provides a system for treating apatient's lung. This system includes a flow control element sized andconfigured to be positioned in a hollow structure located in a patient'slung, wherein the flow control element allows fluid flow in a firstdirection but substantially prevents fluid flow in a second direction,and a removal device for removing the flow control element from thehollow structure subsequent to positioning the flow control element inthe hollow structure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an elevation view schematically showing a system constructedaccording to one embodiment of the invention, the system being used toperform a pulmonary procedure on a patient;

FIG. 2 is an enlarged elevation view of the lungs of the patient shownin FIG. 1 along with the system of the invention;

FIG. 3 is an enlarged elevation view, in section, of a flow controlelement forming part of the system shown in FIG. 2, wherein the flowcontrol element allows fluid flow in a first direction but blocks fluidflow in a second direction;

FIG. 4 is an enlarged elevation view, in section, of an alternative flowcontrol element that allows fluid flow in a first direction but blocksfluid flow in a second direction;

FIG. 5 is an enlarged elevation view, in section, of another alternativeflow control element;

FIG. 6 is an enlarged elevation view, in section, of still anotheralternative flow control element;

FIG. 7 is a perspective view of an introducer constructed according toanother embodiment of the invention;

FIG. 8 is an enlarged perspective view of a portion of the introducershown in FIG. 7;

FIG. 9 is a perspective view of a delivery device constructed accordingto another embodiment of the invention for delivering a flow controlelement to a selected location in a patient's lung;

FIG. 10 is a perspective view of a measuring device constructedaccording to another embodiment of the invention for determining thesize of a hollow structure prior to disposing a flow control element inthe structure; and

FIG. 11 is a perspective view of a removal device constructed accordingto another embodiment of the invention for removing a flow controlelement that has already been positioned in a hollow structure.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The present invention provides methods and devices for performingpulmonary procedures, for example, treating various lung diseases suchas emphysema and COPD. One preferred embodiment of the inventionprovides a flow control element that allows fluid flow in a firstdirection and controls fluid flow in a second direction. As used herein,fluid means gas, liquid, or a combination of a gas(es) and liquid(s). Inaddition, controlled fluid flow, as used herein, means that the flow isaltered in some manner, i.e., the flow is not unimpeded in the seconddirection. The specific manner in which fluid flow is controlled in thesecond direction depends on the construction of the flow controlelement. The flow control element may, for example, completely block,substantially block, limit, meter or regulate fluid flow in the seconddirection by a valve or other suitable structure.

As an example, when positioned in a hollow structure in a patient'sbody, such as a bronchiole in one of the lungs, the flow control elementis oriented to allow flow in the exhalation direction but prevent fluidflow in the inhalation direction. The flow control element has a valvemember that opens during exhalation in order to deflate or decompressthe isolated lung portion distal to the flow control element. Thismaintains the diseased tissue in a decompressed state which preventsfurther hyper-expansion of the tissue. The invention also permits slowdecompression of the lung tissue over a short or extended period oftime.

The invention thus may be used to prevent fluid being drawn into one oremore portions of a patient's lung. According to another aspect of theinvention, a portion of the lung may be deflated by applying gentlesuction (via the flow control element) to the hyper-expanded tissuewithout collapsing the walls of the narrow airways surrounded bydiseased tissue. The suction draws air, liquid, mucous, etc., out of thelung portion to evacuate the diseased tissue. It will be recognized thatthese and other aspects of the invention may be practiced independentlyor in conjunction with each other.

FIG. 1 is a schematic view showing a system 10 constructed according toone embodiment of the invention for carrying out a pulmonary procedureon the lung L of a patient P. It should initially be noted that suitablesystems, methods or devices outside of those specifically describedherein may be used to practice the invention. As such, the system 10 isexemplary only and includes a bronchoscope 12 having a steeringmechanism schematically indicated at 14, a shaft 16, and a port 18 whichprovides access to one or more working channels of the bronchoscope.

FIG. 1 shows a delivery device 20 constructed according to theinvention. The delivery device 20 is shown positioned in thebronchoscope 12 in order to deliver a flow control element 22. Thebronchoscope 12 has been passed into the patient's trachea T and guidedinto the right bronchus 24. The delivery device 20 is then manipulatedwith respect to the bronchoscope 12 via steering mechanism 14 to controlplacement of the flow control element 22. With reference to FIGS. 1 and7-9, the delivery device 20 is movable within a bronchoscope workingchannel 26 (FIG. 8) and is guided into the desired location in thehollow structure, which in this case is a bronchiole 28. For purposes ofexplanation, the bronchiole 28 feeds an upper lobe U of the lung L whichrepresents a diseased lung portion. The delivery device 20 is placedthrough the side port 18 and into the working channel 26, the distal end30 of the delivery device 20 is moved out of the working channel, andthe flow control element 22 is secured in position in the bronchiole 28.

FIG. 2 is an enlarged view of the patient's lungs L shown in FIG. 1after the introducer 12 and delivery device 20 have been removed, theflow control element 22 being left in the bronchiole 28. The flowcontrol element 22, shown in more detail in FIG. 3, is in the form of avalve with a valve member 32 supported by a ring 34. It should be notedthat FIG. 2 also illustrates a second flow control element 22A placed ina bronchiole 28A that feeds a lower lobe LL of the lung. The flowcontrol element 22A includes a valve member 32A and a support ring 34Aand reduces or prevents fluid from being inhaled into the hyper-expandedtissue of the lower lobe LL. It will be understood that any number offlow control elements may be used in a given procedure.

Referring to FIG. 3, which shows the flow control element 22 in detail,the valve member 32 is a duckbill-type valve and has two flaps definingan opening 36. The valve member 32 is shown in a flow-preventingorientation in FIG. 3 with the opening 36 closed. The valve member 32 isconfigured to allow fluid flow in a first direction (along arrow A)while controlling fluid flow in a second direction (along arrow B). Inthis embodiment, fluid flow in the direction of arrow B is controlled bybeing completely blocked by valve member 32. The first and seconddirections in which fluid flow is allowed and controlled, respectively,are preferably opposite or substantially opposite each other, forexample, as shown in the Figures. It will be appreciated, though, thatthe invention may be practiced with the first and second directionsdifferent but not opposite each other.

As noted above, the valve member 32 of the flow control element 22controls fluid flow by completely blocking such flow in the seconddirection. As such, the valve member 32 effectively functions as aone-way valve. Alternative embodiments of the invention utilize flowcontrol elements that controls fluid flow in the second directionwithout completely blocking such flow.

FIG. 4 shows an exemplary flow control element 38 constructed accordingto an alternative embodiment of the invention that limits, but does notblock, fluid flow in at least one direction. The flow control element 38comprises a valve member 40 supported by a ring 42. The valve member 40is preferably a duckbill-type valve having a similar construction tothat of the valve member 32, except that the flaps 44 are formed,secured, oriented or otherwise configured to maintain a flow opening 46when in their flow-controlling (as opposed to flow-allowing)orientation. The opening 46 is sized and configured to achieve desiredflow characteristics through the flow control element 38.

When the flow control element 38 is in its flow-allowing orientation(not shown), the flaps 44 spread apart and allow essentially unimpededfluid flow out of the diseased lung portion. When the flow controlelement 38 is in its flow-controlling orientation, as shown in FIG. 4,the flaps move together to define opening 46 which allows apredetermined amount of fluid to be inhaled into the lung portion. Thisis in contrast to flow control element 22 which blocks fluid flow intothe lung when in a flow-controlling orientation. It will of course berecognized that FIG. 4 shows only one way to achieve limited fluid flowin a given direction. The specific manner in which flow control isobtained may vary according to the invention, e.g., by varying thenumber, size, shape or position of the flow openings on the flow controlelement.

According to another aspect of the invention, the flow control elementmay be constructed to provide a pumping action that aids in moving gasor liquid within a hollow structure, such as a bronchiole. For instance,when the lung distorts during inhalation and/or exhalation, a mechanicalpumping action is produced that may be used to move the gas or liquid tofurther deflate the isolated region of the lung. FIG. 5 shows anexemplary flow control element 50 constructed according to thisembodiment and including a pair of valve members 52, 54 supported inseries by a ring 56. The valve members 52, 54 each include a pair offlaps defining a valve opening (the valve members being shown in theirclosed, fluid flow blocking orientation in FIG. 5). A chamber 58 isdefined between the valve members 52, 54 and produces a pumping effecton the fluid flowing through the flow control element 50. The chamberwould collapse and expand with movement of the bronchiole (or otherhollow structure in which it is inserted) to pump fluid from thediseased lung tissue.

The valve member 54 is coupled to a bellows 60 to enhance the pumpingaction and/or to control the amount of force needed to open the valvemember. The wall 62 defining the chamber 58 is secured to the ring 56 sothat the chamber 58 occupies the entire interior of the ring 56. Theflow control element 50 may have a different configuration wherein thechamber 58 is defined by an air pocket located within the wall 62. Thismay prevent fluid collecting in the chamber 58. In addition, apower-driven pump may be used to draw fluid out of the lungs, e.g., aminiature battery-powered electric pump, or pumps that use physical orchemical characteristics, e.g., a change in air temperature, presence ofan additional gas or liquid, change in pH, etc., to generate pumpingforce that evacuates air and mucous.

FIG. 6 shows yet another alternative flow control element 70 including avalve member 72 comprising a pair of flaps defining an opening, and ring74 supporting the valve member 72. The valve member 72 is aduckbill-type valve that permits fluid flow in a first direction butprevents flow in a second direction. The ring 74 in this embodimentcomprises a stent 76 having struts 78 to enhance fixation of the flowcontrol element 70 in the hollow body structure (not shown). The valvemember 72 may be attached to the stent 76 by any suitable means, e.g.,suture, fasteners, adhesives, etc. The stent 76 is movable betweencollapsed and expanded (FIG. 6) orientations to enable easy delivery anddeployment. That is, the flow control element 70 including stent 76 maybe collapsed and held in a sheath for delivery through a relativelysmall space, for example, the working channel of a bronchoscope. (Atypical bronchoscope has a diameter of about 6 or 7 mm, while theworking channel has a diameter of about 2 or 3 mm.) Utilizing acollapsible flow control element may also be useful in introducing theflow control element through an small opening formed in the patient'sthorax.

FIGS. 7 and 8 show in detail the bronchoscope 12 and the flow controlelement delivery device 20 described above in connection with FIG. 1.The bronchoscope 12 has an eyepiece 80 which is used to visualize thetrachea and the various pathways of the lung during deployment of theflow control element 22. The bronchoscope 12 may be provided with acamera/recorder, an aspiration/irrigation system, or other auxiliaryfeatures. The steering mechanism 14 may comprise cables that move thedistal tip of the bronchoscope shaft 16 over a desired angular range,for example, 0° through 180°. FIG. 8 shows the distal portion 30 of thebronchoscope 12 including the working channel 26 (which communicateswith the side port 18), one or more fiber optic light guides 81, and alens 82 for transmitting images to the eyepiece 80.

FIG. 9 shows the delivery device 20 to include a handle 84, an actuator86, a support shaft 87 and a sheath 88. For purposes of illustration,the delivery device 20 will be described in connection with deliveringthe flow control element 70 of FIG. 6, although it will be understoodthat it may be used to deliver alternative flow control elements. Theflow control element 70, and in particular the stent 76, is collapsed toa low profile orientation and then mounted on the shaft 87. The sheath88 is moved distally from the position shown in FIG. 9 until it coversthe stent body 76 (and the valve member 72, if desired) to maintain theflow control element 70 collapsed. (This position of the sheath isomitted for clarity.) The shaft 87 and sheath 88 are then passed intothe side port 18 and working channel 26 of the bronchoscope 12 andguided to a desired location in the lung. The actuator 86 is used toremove the sheath 88 from the flow control element 70 which allows thestent 76 to expand. Stent 76 is preferably formed of a self-expandingmaterial, e.g., nitinol. In this case the flow control element 70immediately expands and engages the tissue upon retraction of sheath 88.Alternatively, the stents could rely on a mechanism such as a balloon orheat activation to expand in use.

The flow control element of the invention may be guided to andpositioned at a desired location in the pulmonary system, such as thebronchiole 28 shown in FIGS. 1 and 2, by various delivery devices orsystems. For example, guidewire-based systems, introducer sheaths,cannulae or catheters, etc., may be used to deliver the treatmentelement in a minimally invasive manner. The above-described method forusing a bronchoscope to introduce the flow control element may bemodified by placing an introducer sheath over the bronchoscope. Thesheath provides access should the bronchoscope need to be removed frompatient's body, for example, in order to place a different size flowcontrol element.

The invention is preferably carried out by first determining theapproximate size of the target lumen, i.e., the hollow structure inwhich the flow control element will be placed. FIG. 10 shows somewhatschematically an exemplary device for determining the size of a hollowstructure in a patient's body, for example, a bronchiole in a lung. Thedevice 90 includes a housing 92, shaft 94, positioning element, 96 andmeasuring elements 98. The measuring elements 98 have tips 100 that aremoved into contact with the wall of the hollow structure, such as theinner surface of a bronchiole (not shown). The device 90 is calibratedso that when tips 100 of measuring elements 98 engage the wall of thebronchiole the indicator 102 displays the approximate size of thebronchiole. An electrical coupling 104 powers the device 90.

The positioning element 96 is optional and may be used to fix theposition of the measuring elements 98 within the bronchiole so as toobtain more precise measurement. The illustrated element 96 is aninflatable balloon, although other elements could be used to center andhold the shaft 96 within the bronchiole. Any suitable means may be usedfor ensuring that the measuring elements 98 do in fact contact thebronchiole wall in order to provide a true reading. The measuringelements 98 may be moved distally (to the right in FIG. 10) until avisual indicator indicates that the tips 100 are in contact with tissue.Alternatively, a change in electrical resistance may be used to confirmcontact between the measuring elements 98 and tissue. It should be notedthat the device 90 is merely representative of the various means thatmay be used to determine the size of a hollow body structure.

In use, the shaft 94 of the measuring device 90 is passed through thebronchoscope working channel 26 and delivered to the site. The device 90is then operated as described above to determine the approximate size ofthe bronchiole. The degree of precision with which the size of thehollow structure is measured will depend on the procedure beingperformed and user preference. After determining the size of thebronchiole the device 90 is removed from working channel 26, anddelivery device 20 is inserted into the channel to deploy the flowcontrol element in the bronchiole.

It may in some instances be necessary or desirable to remove a flowcontrol element from a hollow structure in which it has been deployed.As an example, it may be the case that placement of a flow controlelement for a given period of time effects beneficial results on thediseased lung tissue. The time during which the diseased tissue isdeflated and decompressed may allow the tissue to regain some elasticityas a result of being temporarily inactive. After the tissue has regainedsome or all of its elasticity, it would be better to remove the flowcontrol element and allow the tissue to function efficiently. The flowcontrol element, however, is preferably not removed before the tissuehas a sufficient chance to recover.

Accordingly, the invention also provides methods and devices forremoving a flow control element from a hollow structure such as abronchiole in a patient's body. FIG. 11 shows a device 110 comprising ahandle 112, an actuator 114, a shaft 116 and one or more removalcomponents 118. The components 118 preferably have tips 120 configuredto grasp a flow control element in order to remove the element fromsurrounding tissue. The shaft 116 of the device 110 is passed into apatient's trachea (not shown) and is guided to the previously-deployedflow control element; for example, the shaft 116 may be introducedthrough the working channel of a bronchoscope in the same manner as thedelivery device 20. The removal components 118 are preferably collapsedwithin shaft 116 while the shaft is guided to the site. The components118 are then extended into contact with the wall of the bronchiole. Thetips 120 are used to grasp and remove the flow control element from thebronchiole.

The flow control element of the invention is secured in position in thehollow structure, such as bronchiole 28, so as to remain in place duringbreathing. The exterior of the flow control element may be configuredalong all or part of its exterior to aid in fixing the element in place,for instance, as schematically indicated by reference numeral 48 inFIGS. 3 and 4. The fixation structure 48 may comprise adhesives, tissuegrowth-inducing substances, fasteners, staples, clips, suture, stents,balloons, Dacron® sleeves, sintered, etched, roughened, barbed oralternatively treated surfaces, etc.

Placement of a flow control element constructed according to theinvention in a patient's pulmonary system achieves several benefits.With reference to the illustrated flow control element 22, when deployedin the bronchiole 28 as shown in FIGS. 1 and 2, the element allowsexhalation but prevents inhalation. The flow control element 22 thuslimits or prevents the inhalation of additional fluid into the diseasedlung portion. This is beneficial because it prevents further enlargementof the hyper-expanded tissue, which in turn maintains more room in thepleural space for healthy lung tissue. The flow control element 22 alsoallows any air being naturally exhaled by the patient (as well as anyliquid, if present) to exit the lung, thereby deflating or decompressingthe tissue. The fluid is preferably permitted to flow unimpeded from thelung, but it may instead be metered or regulated in order to controldeflation.

The flow control elements of the invention permit the diseased tissue togradually deflate, either under the patient's own power or by applyingrelatively gentle suction for a given period of time. The suction may beapplied intermittently or continuously by any suitable means. Forexample, a suction catheter could be passed through the flow controlelement in the bronchiole and into the distal tissue. The flow controlelement, for example, a valve member, would preferably seal around thecatheter in order to prevent fluid moving distally past the valve.

The invention thus provides significant benefits as it permits fluid tobe evacuated from the alveoli without collapsing the floppy walls of thenarrow airways leading to them, problem with common lung diseases suchas emphysema and COPD, as discussed above. Accordingly, the inventionfacilitates removal of more fluid from the diseased lung tissue thanprior art approaches, the effect of which is more plural space availableto the healthy lung tissue.

In addition, as noted above, using the invention to deflate the diseasedlung tissue for a selected period of time, e.g., one month, may havebeneficial results on the tissue by temporarily removing it from therespiratory circuit. The flow control element is preferably removedbefore the tissue begins to necrose, but is left in place a sufficientlylong enough time that the tissue will not revert to its floppy, tonelessstate when the element is removed. Stated otherwise, it may be possibleto use the invention as a means for repairing (rather than removing orobliterating) diseased lung tissue, either by controlling the fluid flowin the lung tissue or by controlling the fluid flow in combination withdelivering one or more substances.

For example, some possible substances with which the invention may beused include gene therapy or angiogenesis factors for lung repair orre-establishment of tissue elasticity; growth factors; anti-growth oranti-angiogenesis factors (or substances to cause necrosis or apoptosis)to prevent re-establishment of air and blood flow; antibiotics toprevent infection; anti-inflammatory agents including steroids andcortisones; sclerosing drugs or materials to promote rapid healing, forexample, to allow earlier removal of the flow control element; agentsfor absorbing remaining fluids; and sealing substances for enhancingisolation of the diseased tissue.

The portion of the lung being treated may be deflated over time throughrepeated natural inhalation and exhalation with the flow control elementin place. Alternatively or additionally, a vacuum source may be coupledto the flow control element to draw fluid out of the diseased tissue inthe manner discussed above. This deflation of the diseased portion maybe performed alone or in conjunction with delivering biologicalsubstances. The pressures used to suction the lung portion arepreferably low to avoid collapsing the walls of the narrow airways.

In the embodiments in which the flow control element comprises a valve,it may be formed of various materials and may be constructed in variousmanners. As an example, the valve may comprise an annulus or supportring formed of any suitable metal or synthetic material, with the valvemember being formed of silicone, natural rubber, latex, polyurethane,polytetrafluoroethylene, a thermoplastic elastomer, tissue, etc. Thevalve member may be integral with the support ring or it may be aseparate member attached thereto by suitable means, e.g., suture,adhesives, mechanical fasteners, etc. If the flow control elementcomprises a stent with a valve, prior art attachment methods may beused. For example, see U.S. Pat. No. 5,954,766, the content of which isincorporated herein by reference.

The specific characteristics of the flow control element may be varieddepending on the particular application. It may be desirable to providemultiple flow control elements with valve members that require differentexhale pressures to open, for example, in order to allow treatment ofpatients who generate different exhalation pressures. The different flowcontrol elements could be provided in a kit and be distinguished fromeach other based on required opening force, size, material, etc. The kitcould include a color or other coding system to indicate these factors.

The flow control elements of the invention are preferably constructed soas to require a relatively low opening force in order to allow fluidflow in the first direction. Emphysema patients typically exhale a smallquantity of low-pressure fluid. The invention preferably allows any suchfluid to escape via the flow control element in the hollow structure. Assuch, the flow control element is designed to open and allow flow in thefirst direction in response to any positive pressure generated by thepatient. Put another way, as long as some pressure differential existsbetween the distal lung tissue and the proximal portion of thebronchiole, the flow control element will open to allow fluid to escapethe tissue. It will nonetheless be recognized that the particular forcerequired to open the flow control element may be varied depending onexhalation pressures associated with the intended patient population.

It will be appreciated that features of the various preferredembodiments of the invention may be used independently or in conjunctionwith one another, while the illustrated methods and devices may bemodified or combined in whole or in part. The inventive devices mayinclude removable or detachable components, and may comprise disposableor reusable components, or a combination of disposable and reusablecomponents. Likewise, it will be understood that the invention may bepracticed with one or more of the steps specifically illustrated anddescribed herein modified or omitted.

It should also be recognized that the invention is not limited totreating lung diseases as is shown in the Figures, although that is apreferred application. The invention may be used in any pulmonary ornon-pulmonary procedure in which it is desirable to allow fluid flow ina first direction and control fluid flow in a second, differentdirection within a hollow structure. Finally, it will be understood thatalthough a minimally invasive, endobronchial approach is shown in theFigures, other approaches may used, for example, an open surgicalprocedure using a median sternotomy, a minimally invasive procedureusing a mini thoracotomy, or a still less invasive procedure using oneor more ports or openings in the thorax, etc.

The preferred embodiments of the invention are described above in detailfor the purpose of setting forth a complete disclosure and for sake ofexplanation and clarity. It will be readily understood that the scope ofthe invention defined by the appended claims will encompass numerouschanges and modifications.

1. A system for use in a lung of a patient comprising: a scope adaptedfor viewing a lung passageway in the lung, the scope having a shaftpositionable in the patient's trachea and a working channel in theshaft; a delivery device movably positionable in the working channel; aflow control element releasably coupled to the delivery device andadapted for implanting in the lung passageway to restrict fluid flow inat least an inspiration direction therethrough, wherein the deliverydevice comprises a support shaft configured for coupling to the flowcontrol element and a sheath slidably disposed over the support shaftand configured to cover at least a portion of the flow control element,the sheath having an opening at a distal end thereof for insertion andremoval of the flow control element; and an actuator associated with thedelivery device for moving the sheath relative to the shaft to releasethe flow control element through the distal opening in the sheath. 2.The system of claim 1, wherein the flow control element is movablebetween a collapsed configuration for positioning into the lungpassageway and an expanded configuration for implanting in the lungpassageway.
 3. The system of claim 2, wherein the delivery device isadapted to hold the flow control element in the collapsed configuration.4. The system of claim 2, wherein the flow control element comprises astent movable between a collapsed configuration and an expandedconfiguration.
 5. The system of claim 4, wherein the stent comprises aresilient material so as to self-expand from the collapsed configurationto the expanded configuration.
 6. The system of claim 1, wherein theflow control element comprises a fixation structure thereon to aid infixing the flow control element in place in the lung passageway.
 7. Thesystem of claim 6, wherein the fixation structure comprises a pluralityof barbs for engaging a wall of the lung passageway.
 8. The system ofclaim 1, wherein moving the actuator decouples the flow control elementfrom the delivery device.
 9. The system of claim 1, wherein the flowcontrol element comprises a valve which restricts fluid flow in theinspiration direction and allows fluid flow in the expiration direction.10. The system of claim 1, wherein the bronchoscope has a distal end,the delivery device being movable distally of the distal end so that theflow control element is visible through the scope.
 11. The system ofclaim 1, wherein the flow control element is movably positionable withinthe working channel.
 12. The system of claim 1, wherein the scope has aport at a proximal end thereof in communication with the workingchannel, the delivery device being positionable through the port.
 13. Asystem for treating a lung of a patient through a working channel of abronchoscope positioned in the patient's trachea, the system comprising:a delivery device movably positionable in the working channel; a flowcontrol element releasably coupled to the delivery device and adaptedfor implanting in the lung passageway to restrict fluid flow in at leastan inspiration direction therethrough, wherein the delivery devicecomprises a support shaft configured for coupling to the flow controlelement and a sheath slidably disposed over the support shaft andconfigured to cover at least a portion of the flow control element, thesheath having an opening at a distal end thereof for insertion andremoval of the flow control element; and an actuator associated with thedelivery device for moving the sheath relative to the shaft to releasethe flow control element through the distal opening in the sheath. 14.The system of claim 13, wherein the flow control element is movable acollapsed configuration for positioning into the lung passageway and anexpanded configuration for implanting in the lung passageway.
 15. Thesystem of claim 14, wherein the delivery device is adapted to hold theflow control element in the collapsed configuration.
 16. The system ofclaim 14, wherein the flow control element comprises a stent movablebetween a collapsed configuration and an expanded configuration.
 17. Thesystem of claim 16, wherein the stent comprises a resilient material soas to self-expand from the collapsed configuration to the expandedconfiguration.
 18. The system of claim 13, wherein the flow controlelement comprises a fixation structure thereon to aid in fixing the flowcontrol element in place in the lung passageway.
 19. The system of claim18, wherein the fixation structure comprises a plurality of barbs forengaging a wall of the lung passageway.
 20. The system of claim 13,wherein moving the actuator decouples the flow control element from thedelivery device.
 21. The system of claim 13, wherein the flow controlelement comprises a valve which restricts fluid flow in the inspirationdirection and allows fluid flow in the expiration direction.
 22. Thesystem of claim 13, wherein the bronchoscope has a distal end, thedelivery device being movable distally of the distal end so that theflow control element is visible through the scope.
 23. The system ofclaim 13, wherein the flow control element is movably positionablewithin the working channel.
 24. The system of claim 13, wherein thescope has a port at a proximal end thereof in communication with theworking channel, the delivery device being positionable through theport.
 25. A method for treating a patient's lung, the method comprisingsteps of: providing a flow control element which restricts fluid flow inat least a first direction, the flow control element being releasablycoupled to a delivery device; inserting a bronchial access device in abronchial passageway of a patient's lung, the bronchial access devicehaving a first channel and a second channel; positioning the deliverydevice in the second channel; and deploying the flow control element atthe treatment site; wherein the inserting step comprises positioning adistal end of the bronchial access device in a first bronchialpassageway and the deploying step comprises placing the flow controlelement in a second bronchial passageway branching from the firstbronchial passageway.
 26. The method of claim 25, further comprisingvisualizing a treatment site in the patient's lung through the firstchannel.
 27. The method of claim 25, wherein the bronchial access devicecomprises a bronchoscope.
 28. The method of claim 25, wherein the flowcontrol element restricts flow in only the first direction.
 29. Themethod of claim 28, wherein the flow control element comprises a valve.30. The method of claim 29, wherein the valve is selected from the groupconsisting of duckbill, flapper, tricuspid, ball and needle valves. 31.The method of claim 25, wherein at least a portion of the flow controlelement has a first diameter before the deploying step and a seconddiameter when deployed at the treatment site, the first diameter beingless than the second diameter.
 32. The method of claim 31, wherein theflow control element comprises a stent, and wherein during the deployingstep the stent expands from the first diameter to the second diameter.33. The method of claim 25, wherein the flow control element is advancedthrough the second channel during the positioning step.
 34. The methodof claim 25, wherein the delivery device is positioned in the secondchannel after the inserting step.
 35. The method of claim 25, furthercomprising visualizing the flow control element through the firstchannel during the step of deploying.
 36. The method of claim 25,wherein the bronchial access device includes a camera.
 37. The method ofclaim 25, wherein the visualizing step comprises transmitting lightthrough a lens.
 38. The method of claim 25, further comprising, prior tocarrying out the deploying step, determining the approximate size of thetreatment site, and selecting an appropriately sized flow controlelement based at least in part on the determined size of the treatmentsite.
 39. The method of claim 38, wherein the determining step iscarried out using a measuring device.
 40. The method of claim 25,further comprising the step of applying suction to at least part of thelung located distally of the flow control element.
 41. A method fortreating a patient's lung, the method comprising steps of: providing aflow control element which restricts fluid flow in at least a firstdirection, the flow control element being releasably coupled to adelivery device, wherein the delivery device has a sheath, the sheathhaving an opening at a distal end thereof; inserting a bronchial accessdevice in a bronchial passageway of a patient's lung, the bronchialaccess device having a first channel and a second channel; positioningthe delivery device in the second channel; and deploying the flowcontrol element at the treatment site, the deploying step comprisingmoving the sheath relative to the flow control element to release theflow control element through the distal opening in the sheath.
 42. Themethod of claim 41, further comprising visualizing the flow controlelement through the first channel during the step of deploying.
 43. Themethod of claim 41, wherein the bronchial access device includes acamera.
 44. The method of claim 41, wherein the visualizing stepcomprises transmitting light through a lens.
 45. The method of claim 41,wherein the inserting step comprises positioning a distal end of thebronchial access device in a first bronchial passageway and thedeploying step comprises placing the flow control element at a secondbronchial passageway branching from the first bronchial passageway. 46.The method of claim 41, further comprising, prior to carrying out thedeploying step, determining the approximate size of the treatment site,and selecting an appropriately sized flow control element based at leastin part on the determined size of the treatment site.
 47. The method ofclaim 41, further comprising the step of applying suction to at leastpart of the lung located distally of the flow control element.
 48. Themethod of claim 41, wherein the bronchial access device comprises abronchoscope.